No major non-conformities
No minor non-conformities
Only one comment released
This is the more than positive outcome of the surveillance audit on the ISO 13485 certification just carried out at Novotema.
This certification relates to a specific quality management system standard for companies operating in the medical sector… so what does it have to do with Novotema?
In Novotema since years we have been co-designing and producing highly customized sealing solutions and special components also for the medical and pharmaceutical markets, in elastomeric materials and liquid and paste silicones.
For these markets the accuracy in performance, resistance to liquids, body fluids and gases, the low levels of contamination and the biocompatibility are extremely important.
We are also equipped with an ISO Class VIII certified clean room which we use for sorting and packaging of components requiring high standards of cleanliness.
Novotema: Safety first, Quality always!
